Abstract
Single-agent bortezomib (B) has shown activity in heavily pretreated patients with relapsed/refractory indolent lymphoma. On the basis of these findings, we performed a phase II study of B combined with rituximab (R) in patients with relapsed follicular lymphoma (FL). Forty-five patients with fairly good prognostic profiles were enrolled from 2007 to 2011 and received a total of 6 cycles of the B+R combination. The endpoints were the overall response rate (ORR), progression-free survival (PFS), duration of remission (DoR), overall survival (OS), and toxicity evaluation. When considering all the enrolled patients the ORR was 64%. At 5 years, the estimated PFS, DoR, and OS were 34, 49, and 70%, respectively. After excluding the 7 R-naïve patients, the ORR was 58%, with a PFS of 19 months. The most common grade >2 toxicities were thrombocytopenia (18%), peripheral neuropathy (13%), and neutropenia (2%). Our study shows the feasibility, long-term efficacy, and excellent tolerability of the B+R combination. We are aware that our study has specific limitations, such as the small sample size consisting of patients with a relatively good prognostic profile. However, because FL patients will be treated with subsequent chemotherapy regimens, a well-tolerated and effective chemotherapy-free therapy could be considered an additional tool for long-term disease control.
| Original language | English |
|---|---|
| Pages (from-to) | 7-14 |
| Number of pages | 8 |
| Journal | Acta Haematologica |
| DOIs | |
| Publication status | Accepted/In press - Nov 4 2016 |
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Keywords
- Bortezomib
- Chemotherapy-free regimen
- Follicular lymphoma
- Relapsed/progressive disease
- Rituximab
ASJC Scopus subject areas
- Medicine(all)
- Hematology
Cite this
A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma : Long-Term Follow-Up. / Bari, Alessia; Marcheselli, Raffaella; Marcheselli, Luigi; Alvarez De Celis, Maria Isabel; Pozzi, Sacchi Samantha; Ferri, Paola; Lazzaro, Antonio; Fragasso, Alberto; Neri, S.; Baldini, Luca; Carella, Angelo Michele; Angrilli, F.; Guariglia, Roberto; Buda, Gabriele; Stelitano, Caterina; Sacchi, Stefano.
In: Acta Haematologica, 04.11.2016, p. 7-14.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A Multicenter Phase II Study of Twice-Weekly Bortezomib plus Rituximab in Patients with Relapsed Follicular Lymphoma
T2 - Long-Term Follow-Up
AU - Bari, Alessia
AU - Marcheselli, Raffaella
AU - Marcheselli, Luigi
AU - Alvarez De Celis, Maria Isabel
AU - Pozzi, Sacchi Samantha
AU - Ferri, Paola
AU - Lazzaro, Antonio
AU - Fragasso, Alberto
AU - Neri, S.
AU - Baldini, Luca
AU - Carella, Angelo Michele
AU - Angrilli, F.
AU - Guariglia, Roberto
AU - Buda, Gabriele
AU - Stelitano, Caterina
AU - Sacchi, Stefano
PY - 2016/11/4
Y1 - 2016/11/4
N2 - Single-agent bortezomib (B) has shown activity in heavily pretreated patients with relapsed/refractory indolent lymphoma. On the basis of these findings, we performed a phase II study of B combined with rituximab (R) in patients with relapsed follicular lymphoma (FL). Forty-five patients with fairly good prognostic profiles were enrolled from 2007 to 2011 and received a total of 6 cycles of the B+R combination. The endpoints were the overall response rate (ORR), progression-free survival (PFS), duration of remission (DoR), overall survival (OS), and toxicity evaluation. When considering all the enrolled patients the ORR was 64%. At 5 years, the estimated PFS, DoR, and OS were 34, 49, and 70%, respectively. After excluding the 7 R-naïve patients, the ORR was 58%, with a PFS of 19 months. The most common grade >2 toxicities were thrombocytopenia (18%), peripheral neuropathy (13%), and neutropenia (2%). Our study shows the feasibility, long-term efficacy, and excellent tolerability of the B+R combination. We are aware that our study has specific limitations, such as the small sample size consisting of patients with a relatively good prognostic profile. However, because FL patients will be treated with subsequent chemotherapy regimens, a well-tolerated and effective chemotherapy-free therapy could be considered an additional tool for long-term disease control.
AB - Single-agent bortezomib (B) has shown activity in heavily pretreated patients with relapsed/refractory indolent lymphoma. On the basis of these findings, we performed a phase II study of B combined with rituximab (R) in patients with relapsed follicular lymphoma (FL). Forty-five patients with fairly good prognostic profiles were enrolled from 2007 to 2011 and received a total of 6 cycles of the B+R combination. The endpoints were the overall response rate (ORR), progression-free survival (PFS), duration of remission (DoR), overall survival (OS), and toxicity evaluation. When considering all the enrolled patients the ORR was 64%. At 5 years, the estimated PFS, DoR, and OS were 34, 49, and 70%, respectively. After excluding the 7 R-naïve patients, the ORR was 58%, with a PFS of 19 months. The most common grade >2 toxicities were thrombocytopenia (18%), peripheral neuropathy (13%), and neutropenia (2%). Our study shows the feasibility, long-term efficacy, and excellent tolerability of the B+R combination. We are aware that our study has specific limitations, such as the small sample size consisting of patients with a relatively good prognostic profile. However, because FL patients will be treated with subsequent chemotherapy regimens, a well-tolerated and effective chemotherapy-free therapy could be considered an additional tool for long-term disease control.
KW - Bortezomib
KW - Chemotherapy-free regimen
KW - Follicular lymphoma
KW - Relapsed/progressive disease
KW - Rituximab
UR - http://www.scopus.com/inward/record.url?scp=84994716253&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84994716253&partnerID=8YFLogxK
U2 - 10.1159/000449052
DO - 10.1159/000449052
M3 - Article
SP - 7
EP - 14
JO - Acta Haematologica
JF - Acta Haematologica
SN - 0001-5792
ER -